Hivatkozási szám

MSZ EN IEC 60601-2-75:2020

Dokumentumazonosító

175262

Cím

Gyógyászati villamos készülékek. 2-75. rész: Fotodinamikus terápiás és fotodinamikus diagnosztikai készülékek alapvető biztonságra és lényeges működésre vonatkozó kiegészítő követelményei (IEC 60601-2-75:2017)

Angol cím

Medical Electrical Equipment. Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment (IEC 60601-2-75:2017)

Alkalmazási terület

Clause 1 of the general standard1 applies, except as follows: 201.1.1 Scope Replacement: This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document applies to PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT used for compensation or alleviation of disease, injury or disability. In the case of combined equipment (e.g. equipment additionally provided with a function or an APPLIED PART for the target area) such equipment shall also comply with any particular standard specifying safety requirements for the additional function. This particular standard does not apply to: • light therapy equipment intended for use in photothermal ablation, coagulation, and hyperthermia; • low-level laser therapy equipment not intended for use with a PHOTOSENSITIZER; • illumination equipment intended for use in observation, monitoring, and diagnosis, not intended for use with a PHOTOSENSITIZER. 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for PHOTODYNAMIC THERAPY AND PHOTODYNAMIC DIAGNOSIS EQUIPMENT [as defined in 201.3.214]. 201.1.3 Collateral standards Addition: All collateral standards shall be treated as additional clauses to the general standard. Unless modified in the body of this document, all collateral standards apply to this particular standard. Túl hosszú scope

ICS

11.040.01 Orvostechnikai berendezések általában

Műszaki Bizottság

A szabvány nyelve

angol

Az érvényesség kezdete

2020-07-01

Forrás

idt EN IEC 60601-2-75:2019; idt IEC 60601-2-75:2017

Előd

Utód

Módosítás

SZK-közlemények

Kapcsolódó európai jogszabály

A szabvány

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